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The Impact of Two Strategies in the Monitoring of Exudative ARMD on the Visual Acuity (by OCT B Scan or OCT Angiography) (REPERM-OCT)

Primary Purpose

Age-related Macular Degeneration

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
OCT B-scans
OCT angiography
Sponsored by
Fondation Ophtalmologique Adolphe de Rothschild
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Age-related Macular Degeneration focused on measuring Age-related macular degeneration, Optical coherence tomography angiography

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patient ≥ 50 years old
  • with exudative ARMD,
  • treated with intra-vitreous anti-angiogenics following a PRN protocol (pro re nata)
  • Absence of atrophy of the central pigment epithelium

Exclusion Criteria

  • Opposition to participate in this research
  • Persons enjoying legal protection measure
  • Lack of affiliation to social security and universal health coverage
  • Pregnant or lactating
  • Another cause of Choroidal neovascularization
  • Unbalanced glaucoma
  • Eye surgery less than 3 months on the studied eye

Sites / Locations

  • Fondation Ophtalmologique A. de Rotchschild

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tested patients

Control patients

Arm Description

Patients treated with anti-angiogenics for ARMD : monitoring using optical coherence tomography angiography

Patients treated with anti-angiogenics for ARMD : monitoring during common practice via optical coherence tomography B scans

Outcomes

Primary Outcome Measures

Visual acuity improvement or stabilization
Proportion of patients with visual acuity improvement or stabilization

Secondary Outcome Measures

Full Information

First Posted
August 11, 2016
Last Updated
May 21, 2021
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
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1. Study Identification

Unique Protocol Identification Number
NCT02868086
Brief Title
The Impact of Two Strategies in the Monitoring of Exudative ARMD on the Visual Acuity (by OCT B Scan or OCT Angiography)
Acronym
REPERM-OCT
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
October 21, 2016 (Actual)
Primary Completion Date
November 20, 2020 (Actual)
Study Completion Date
April 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild

4. Oversight

5. Study Description

Brief Summary
The treatment of neovascular age-related macular degeneration (ARMD) is a major issue of public health. The therapeutic arsenal has widely grown throughout the years with the emergence of intra-vitreous anti-angiogenic treatments, under different surveillance protocols. The "PRN" surveillance (pro re nata: an on-demand treatment with monthly follow-up) allows a faster re-injection in case of neovascular relapse in order to maintain the best visual acuity. This therapeutic protocol is guided by the sub-retinal neovascular signs of activity. The monitoring is done during common practice via OCT B scans showing indirect signs of neovascular activity (exudation signs). OCT retinal imaging has been recently enriched with new programs allowing the visualization of sub-retinal neovessels without the use dyes (OCT angiography). The OCT angiography is automatically done by a program using standard OCT sections. During the monitoring of a patient using the OCT A, the signs of renewed neovascular activity are represented by an "arterialization" or the development of an arteriole network of the neovessel with the reappearance of a hyper reflective flow after a neovascular regressive phase. Indeed, the visualization of neovessels during the monitoring by Angio-OCT may lead to therapeutical modifications (anticipation of the injections). Knowing that the injection time-table of ARMD patients treated with anti-angiogenics is determined by sub-retinal neovascular signs of activity. This activity is evaluated during routine clinical practice by very specific signs, observable on OCT B scans. The hypothesis of this study is that the search of activity sins on the Angio-OCT, a new technic of image analysis performed on the OCT, may modify this injection time-table, with an impact of the patient's visual acuity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Macular Degeneration
Keywords
Age-related macular degeneration, Optical coherence tomography angiography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tested patients
Arm Type
Experimental
Arm Description
Patients treated with anti-angiogenics for ARMD : monitoring using optical coherence tomography angiography
Arm Title
Control patients
Arm Type
Active Comparator
Arm Description
Patients treated with anti-angiogenics for ARMD : monitoring during common practice via optical coherence tomography B scans
Intervention Type
Device
Intervention Name(s)
OCT B-scans
Intervention Type
Device
Intervention Name(s)
OCT angiography
Primary Outcome Measure Information:
Title
Visual acuity improvement or stabilization
Description
Proportion of patients with visual acuity improvement or stabilization
Time Frame
Between the inclusion and 1 year of follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patient ≥ 50 years old with exudative ARMD, treated with intra-vitreous anti-angiogenics following a PRN protocol (pro re nata) Absence of atrophy of the central pigment epithelium Exclusion Criteria Opposition to participate in this research Persons enjoying legal protection measure Lack of affiliation to social security and universal health coverage Pregnant or lactating Another cause of Choroidal neovascularization Unbalanced glaucoma Eye surgery less than 3 months on the studied eye
Facility Information:
Facility Name
Fondation Ophtalmologique A. de Rotchschild
City
Paris
ZIP/Postal Code
75019
Country
France

12. IPD Sharing Statement

Learn more about this trial

The Impact of Two Strategies in the Monitoring of Exudative ARMD on the Visual Acuity (by OCT B Scan or OCT Angiography)

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